Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Resmetirom Tablets 80 mg: Take tablet once a day orally, swallowed with water around same time every day for 52 weeks.
Intervention2: Resmetirom Tablets 100 mg: Take tablet once a day o
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of NASH. 2) Historical liver biopsy. 3) Biopsy-proven NASH. 4) Subjects should not have received any medication 5) Documented diagnosis of moderate to advanced liver fibrosis. 6) Subjects receiving antidiabetic, antihypertensive, lipid modifying medication(s) as background therapy. 7) Subject is willing to provide written informed consent document and have ability and willingness to adhere to the protocol. 8) Subjects willing to maintain consistent lifestyle habits. 9) Women of childbearing potential must have a negative urine pregnancy test and agree to use highly effective methods of contraception to prevent pregnancy.
Exclusion criteria
Exclusion criteria: 1) History of cirrhosis or liver-related complications. 2) History of significant alcohol consumption. 3) Subjects with type 1 & 2 diabetes mellitus. 4) Any current or prior history of decompensated liver disease. 5) History or presence of concomitant liver diseases other than NASH at screening. 6) Subjects receiving prohibited drugs. 7) Thyroid diseases. 8) History of weight reduction surgery or planned. 9) History of major or minor surgery or invasive procedure. 10) Subjects with any of the abnormal laboratory values at screening. 11) Subjects with known cases of infection with hepatitis B, hepatitis C or HIV. 12) Known allergy, sensitivity or intolerance to the study drug. 13) Subjects had been participated in any clinical trials for NASH or had been participated in any other investigational drug clinical trial. 14) Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and neither surgically sterilized nor willing to use reliable contraceptive methods. 15) Male subjects who are engaging in sexual activity with female partner of child-bearing potential and not willing to use reliable contraceptive methods throughout the study duration. 16) Any clinically significant condition that in the investigator s opinion may hinder the subject s participation in the study or can interfere with the interpretation of the study results. 17) Subjects with suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percentage change in liver fat content.Timepoint: Baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with resolution of NASH with no worsening of fibrosis as assessed by BiopsyTimepoint: EOT/EOS (week 52);Proportion of subjects with at least a 1-point improvement in fibrosis stage with no worsening of steatohepatitisTimepoint: EOT/EOS (week 52);Mean % change in liver fat contentTimepoint: Baseline to Week 24;Mean absolute change in liver fat.Timepoint: Baseline to EOT/EOS (week 52).;Mean change in liver stiffness and controlled attenuation parameter (CAP)Timepoint: Baseline to EOT/EOS (week 52) ;Mean change in alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT)Timepoint: Baseline to EOT/EOS (week 52);Changes in lipid profile [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high density lipoproteins (HDL) cholesterol, triglycerides (TG)]Timepoint: Baseline to EOT/EOS (week 52);Mean changes in thyroid function testsTimepoint: Baseline to EOT/EOS (week 52) | — |
Countries
India
Contacts
Public ContactMohammad Muneeb Ahsan
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
Outcome results
None listed